Kornimate/medical-research-clean huggingface dataset:
anti-inflammatory dietary intervention for rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the primary objective of this study is to assess if there is a significant difference in the mean disease activity score in individuals with ra participating in a dietary intervention compared to those in the control group measured by das-28. other measures to track disease activity will include monitoring number and severity of disease flares and any changes in medications. this will be done by completing a single-blinded randomized controlled trial, parallel in design. the study population will consist of adults diagnosed with seropositive and seronegative ra based on the american college of rheumatology criteria. participants will have low, moderate, or high disease activity based on das-28 where the investigator feels that they can see improvement from a dietary intervention.

per the schedule of assessments, upon enrollment, participants will be required to come in for a total of five on site visits. the first visit, also known as the baseline visit, will require participants to provided informed consent after all eligibility criteria is met. subsequently, participants' demographics, medical history, eular/acr classification, and physicians' assessments will be documented. participants' vital signs will be checked and a thorough physical exam will also be performed after which safety labs will be drawn in addition to a routine urinalysis. participants will complete outcome surveys and a food frequency questionnaire. participants' body composition will be measured. concomitant medications will be reviewed. each participant will receive nutrition education from an approved md or a consultation with an approved rd depending on the group to which they have been randomized. participants who receive consultations with an rd will have seven follow up visits after the baseline visit.

Eligibility criteria:
inclusion criteria: * age greater than 18 years. * diagnosed ra by a rheumatologist determined by the 2010 acr/eular classification criteria. * low, moderate, or highly active disease state based on clinical assessment where the investigator feels there is potential to see a difference. * able to read and write in english. exclusion criteria: * younger than 18 years. * unable to attend the 8 weekly nutrition appointment. * history of documented eating disorders.
investigating the use of tavns to treat insomnia in individuals with breast cancer (tavns-insomnia-bc)

Conditions: Breast Cancer; Insomnia

Summary: in the present study, the investigators aim to investigate feasibility of utilizing noninvasive neuromodulation, specifically tavns, as a nonpharmacologic approach to address insomnia in patients with stage i-iv breast cancer.

the study will evaluate the feasibility, safety, and tolerability of nightly, at-home self-administered tavns treatments. study staff will monitor for adverse reactions, unanticipated adverse device events and severe adverse events as described to evaluate safety, tolerability, and biocompatibility. additionally, investigators will estimate effect size by collecting outcome assessment data as described below. an additional objective is to use information gained through this study to inform product development activities. specific information about the comfort, ease of use, and other user subject feedback will be used to inform future product development efforts for optimizing device designs. specific aim 1: to evaluate the feasibility of using tavns for patients with breast cancer to treat insomnia. hypothesis: investigators expect that 40 patients with stage i-iii breast cancer and insomnia will be enrolled and undergo tavns to address insomnia, quantified by various sleep related outcome measures, with an estimated recruitment rate of 70%, eligibility rate of 70%, completion rate of 80%, and follow up rate of 80%. specific aim 2: to evaluate the efficacy of repeated, nightly tavns on sleep quality, anxiety, and cancer related fatigue. hypothesis: investigators hypothesize that patients will report improved sleep, anxiety, depression, and cancer related fatigue after one week of tavns.

Eligibility criteria:
inclusion criteria: 1. at least 18 years of age 2. diagnosed stage i-iv breast cancer 3. self-reported difficulty falling asleep, staying asleep, or waking up too early, for at least three nights per week for a duration of at least three months 4. beginning or worsening of sleep disturbance since cancer diagnosis (did your sleep problems begin or get worse with the diagnosis of cancer or with chemotherapy?) 5. english-speaking exclusion criteria: 1. are using a daily sleep aid except melatonin (use of a sleep aid as needed will be permitted, and use will be noted). 2. have a history of severe mental illness 3. have an implanted medical device of any type 4. have a history of seizures 5. have peripheral neuropathy including temporal mandibular disorders and bells palsy 6. have vasovagal syncope 7. have moderate to severe cognitive impairment 8. have \<6 months to live as determined by the physician

Keywords: tavns
a study of pyrotinib plus capecitabine versus lapatinib plus capecitabine in patients with her2+metastatic breast cancer who have prior received anthracyclin, taxane or trastuzumab

Conditions: HER2 Positive Metastatic Breast Cancer

Summary: pyrotinib is an oral tyrosine kinase inhibitor targeting both her-1 and her-2 receptors. this study is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of pyrotinib plus capecitabine versus the combination of lapatinib plus capecitabine in her2+ mbc patients who have prior received anthracyclin, taxane or trastuzumab. patients will be stratified by weather have prior use of trastuzumab and randomized in a 1:1 ratio to one of the following treatment arms: * arm a: pyrotinib (400 mg once daily) + capecitabine (1000 mg/m\^2 twice daily) * arm b: lapatinib (1250 mg once daily) + capecitabine (1000 mg/m\^2 twice daily) patients will receive either arm of therapy until the occurrence of death, disease progression, unacceptable toxicity, or other specified withdrawal criterion.


Eligibility criteria:
inclusion criteria: * aged ≥18 and ≤70 years. * ecog performance status of 0 to 1. * life expectancy of more than 12 weeks. * at least one measurable lesion exists.(recist 1.1). * histologically or cytologic confirmed her2 positive advanced breast cancer which failed prior therapies. * required laboratory values including following parameters: anc: ≥ 1.5 x 10\^9/l;platelet count: ≥ 100 x 10\^9/l;hemoglobin: ≥ 9.0 g/dl;total bilirubin: ≤ 1.5 x upper limit of normal (uln);alt and ast: ≤ 1.5 x uln;bun and creatine clearance rate: ≥ 50 ml/min;lvef: ≥ 50%;qtcf: \< 470 ms for female and \< 450 ms for male. * signed informed consent exclusion criteria: * received previous therapy with lapatinib, neratinib, pyrotinib or any other her2 directe tyrosine kinase inhibitor. * received previous therapy with capecitabine within 3 months.
unsaturated fatty acids enriched-diet to improve cardiorespiratory fitness, metabolic flexibility and glucose tolerance in obese patients

Conditions: Heart Failure With Normal Ejection Fraction; Obesity

Summary: the investigators hypothesize that a dietary intervention aimed at increasing unsaturated fatty acids (ufa) consumption is feasible and has the potential to improve cardiorespiratory fitness, metabolic flexibility and glucose tolerance in symptomatic obese heart failure with preserved ejection fraction (hfpef) patients.

twelve obese hfpef subjects with exercise intolerance (reduce cardiorespiratory fitness measured at maximal cardiopulmonary exercise test \[cpx\]) will be assigned to a single-arm open-label dietary intervention in which subjects are encouraged and financially supported to increase daily ufa consumption. the investigators will measure dietary compliance with a validated 24-hour dietary recall and with objective operator-independent biomarkers of ufa consumption. the investigators will also measure the effects of ufa supplementation on: metabolic flexibility, glucose tolerance and body composition. participants will have the option to participate in overnight session in the whole indirect calorimeter room (wic) at baseline and at the end of the study.

Eligibility criteria:
major inclusion criteria: * body mass index (bmi) ≥30 kg/m2 (obesity) or total body fat percentage \>25% in men and \>35% in women * a confirmed clinical diagnosis of stable hf (new york heart association \[nyha\] class ii-iii) on maximally tolerated heart failure (hf) optimal medical regimen (without major changes in the prior month) * left ventricular ejection fraction (lvef)\>50% documented in the prior 12 months major exclusion criteria: * concomitant conditions or treatment which would affect completion or interpretation of the study (i.e.,physical inability to walk or run on treadmill); * significant ischemic heart disease, angina, uncontrolled arterial hypertension, atrial fibrillation, moderate to severe valvular disease, chronic pulmonary disease, anemia (hemoglobin\<10 g/dl) * electrocardiography (ecg) changes (ischemia or arrhythmias) that limit maximum exertion during cardiopulmonary exercise test * comorbidity limiting survival * stage iv-v kidney disease (estimated glomerular filtration rate\<30) * fluid overload * pregnancy * current use of unsaturated fatty acids (ufa) supplement (i.e., omega-3). * inability to give informed consent

Keywords: obesity heart failure with preserved ejection fraction hfpef unsaturated fatty acids cardiorespiratory fitness dietary intervention
reflexion pet/ct imaging performance in patients with prostate cancer

Conditions: Prostate Carcinoma

Summary: this clinical trial examines reflexion medical radiotherapy system (rmrs) imaging to the standard of care (soc) \[18f\]-dcfpyl positron emission tomography-computed tomography (pet-ct) imaging in patients with prostate cancer. pet is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of a tracer, \[18f\]-dcfpyl, that binds to prostate specific membrane antigen (psma) on tumor cells. these psma tumor cells can then be identified on pet imaging. ct utilizes x-rays that traverse body from the outside. ct images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. the rmrs is a imaging-therapy combination system that can plan for and deliver radiation therapy as well perform \[18f\]-dcfpyl pet-ct imaging. comparing the imaging from the standard of care \[18f\]-dcfpyl-pet-ct with the \[18f\]-dcfpyl imaging from rmrs may help improve the quality of the imaging captured and determine if imaging can be done on the rmrs at the same time as planning for radiation therapy, which would reduce the number of scans needed to plan for radiation for prostate cancer.

primary objective: i. to assess imaging performance of the fluorine f 18 piflufolastat (\[18f\]-dcfpyl) pet-ct subsystem on the x1 rmrs to detect lesions (primary and metastatic) in patients with prostate cancer. secondary objective: i. to determine the feasibility of generating a biology-guided radiotherapy (bgrt) plan using x1 rmrs-acquired \[18f\]-dcfpyl pet data derived from the imaging-only session at the studied dose level. outline: patients receive \[18f\]-dcfpyl intravenously (iv) and undergo \[18f\]-dcfpyl pet-ct over 30 minutes per standard of care (soc). patients with pet avid lesions then undergo a x1 rmrs pet-ct imaging-only session within 120 minutes of injection over 20-35 minutes. after completion of study, patients are followed up within 72 hours.

Eligibility criteria:
inclusion criteria: * documented informed consent of the participant and/or legally authorized representative * age \>= 21 years * patients undergoing soc \[18f\]-dcfpyl pet-ct * patients should be scheduled for \[18f\]-dcfpyl pet-ct prior to study entry exclusion criteria: * known psychiatric or substance abuse disorder that would interfere with conduct of the study * patient weight exceeding the weight limit (450 pounds) outlined per x1 rmrs specifications sheet
objective markers of pain perception in humans

Conditions: Healthy

Summary: determine objective markers of pain perception remains a major scientific and medical issue. various tools have been proposed to objectify pain, but their adaptability to different clinical contexts are limited. our working hypothesis considers that the research for markers of immediate pain perception should be based on an electrophysiological approach, based on the combined analysis of eeg and autonomic responses.

this project aims to study the cortical and autonomic responses induced by tonic painful stimulation compared to those induced by comparable sensory and stressful stimulations, by combining high density eeg, cutaneous sympathetic, cardiovascular and pupillary recordings.

Eligibility criteria:
inclusion criteria: * affiliate or beneficiary of social security * signature of consent exclusion criteria: * history of cardiovascular disease (vagal syncope, hypertension, etc ...), renal, metabolic (diabetes ...), psychiatric (depression, etc ...) or neurological (seizure, etc ...) syndromes; * reynaud's syndrome; * raynaud's disease; * acrocyanosis; * known rhythm disorders; * participation at the same time in another clinical trial; * taking a medical treatment; * suffering from acute (complaint of pain in the week before the test) or chronic pain, * allergic to conductive gel for electrodes.

Keywords: healthy volunteers pain eeg
immunophenotype of risk in older patients admitted for pneumonia

Conditions: Age Associated Immune Deficiency; Elderly Infection; Pneumonia; Nutrition Disorders in Old Age; Frail Elderly Syndrome; Sarcopenia

Summary: the objective is to evaluate if the immune risk phenotype (irp) in patients who have been admitted for pneumonia predisposes to worse long-term outcomes. in addition, the association between the detected immunological alterations and clinical, functional, nutritional or comorbidity risk factors will be evaluated. if the hypothesis is confirmed, helpful immunological markers will be identified. this will be useful in clinical practice to identify patients who can benefit from an intervention and / or to identify the best time for vaccination. otherwise, valuable information will be obtained on the interrelation between immunological, clinical, functional and nutritional aspects.

the objective is to evaluate if the immune risk phenotype (irp) in patients who have been admitted for pneumonia predisposes to worse long-term outcomes. in addition, the association between the detected immunological alterations and clinical, functional, nutritional or comorbidity risk factors will be evaluated. methodology: prospective observational study. it will include 149 patients ≥ 65 years admitted for pneumonia. after 30-45 days of pneumonia diagnosis, a complete clinical, functional, nutritional and immunological assessment will be carried out. fri will be defined as a positive cytomegalovirus serology together with at least one of the following: cd4 / cd8 \ 600 / μl or negative cd28 t cells\> 300 / μl15. mortality and re-admissions at 12 and 18 months will be evaluated. if the hypothesis is confirmed, helpful immunological markers will be identified. this will be useful in clinical practice to identify patients who can benefit from an intervention and / or to identify the best time for vaccination. otherwise, valuable information will be obtained on the interrelation between immunological, clinical, functional and nutritional aspects.

Eligibility criteria:
inclusion criteria: * patients ≥ 65 years old admitted for pneumonia in the "hospital de la santa creu i sant pau in barcelona". exclusion criteria: * patients from another acute care hospital * patients with hiv infection * neutropenic patients (neutrophil count \<1000 / mm3) * transplant patients * patients in end-of-life situation * not having written informed consent.
efficacy of cognitive bias modification in residential treatment for addiction

Conditions: Substance Dependence

Summary: the purpose of this study is to determine whether computer bias modification for interpretation bias (cbm-i) is effective in the reduction of suicidal ideation in substance use disorders.

eighty-eight adult inpatients completing residential treatment in the addictions services at the centre for addiction and mental health (camh) will be randomized to receive cbm-i daily for one week, adjunct to the residential psychosocial treatment or to an assessment-only control condition. participants will complete clinical measures consisting of interviews and questionnaires measuring suicidal ideation, hopelessness, depression, negative affect, and interpretation biases before, during and after treatment.

Eligibility criteria:
inclusion criteria: * exhibit moderate suicide risk or greater * be enrolled in the addictions services inpatient program * fluent in reading english * capacity to give informed consent exclusion criteria: * a lifetime diagnosis of a psychotic or bipolar disorder * significant neurological disorder or psychical illness likely to interfere with participation * psychotropic medication changes within the past two weeks

Keywords: cognitive bias modification interpretation bias suicidal ideation depression
care anywhere with community paramedics program to reduce hospitalization

Conditions: Acute Illness

Summary: the purpose of this research is to compare the effectiveness of the care anywhere with community paramedics program with usual care in a pragmatic randomized controlled trial. the goal of the care anywhere with community paramedics program is to prevent or shorten hospitalizations among patients who are being treated in the clinic/ambulatory setting ("prehospital setting"), emergency department, or hospital and are clinically appropriate to be cared for at home with community paramedic services.

this pragmatic randomized controlled trial will randomize, with 1:1 allocation, 240 adults being treated in the pre-hospital setting, emergency department or hospital to either availability of the care anywhere with community paramedics (cacp) program or to no availability of the cacp program (i.e. usual care). patients randomized to the cacp program will be able to receive in-home medical care - as ordered by their treating clinicians - from the mayo clinic ambulance community paramedic service. primary outcome is going to be days alive spent at home without hospitalization (excluding planned admissions), emergency department visits, or skilled nursing facility care.

Eligibility criteria:
inclusion criteria: * adult (age ≥ 18 years) patients currently admitted to the ed, hospital or are in a pre-hospital setting but being considered for referral to the ed or hospital in mayo clinic rochester, mn and barron, wi but do not require hospital-level monitoring or care other than services that could be delivered by cps in the ambulatory setting. * must reside within approximately a 40-mile radius of rochester, mn or within the service radius of barron, wi. * participants who require assistance with activities of daily living, or who are at increased risk for falls, need to have a caregiver available at home exclusion criteria: * referring clinician and the community paramedic service do not believe the patient to be clinically appropriate for outpatient care with the cacp program. * inability or unwillingness of individual or legal guardian/representative to give written informed consent. * clinical, behavioral, or cognitive instability, determined by the referring clinician or the cacp service. * living conditions unsafe for cps to enter (patient refuses to secure weapons or animals prior to cp's arrival). * enrolled in the trial during an earlier hospitalization or ed visit.

Keywords: community paramedicine acute care home care
a multiple dose safety, tolerability and pharmacokinetics study in adult patients with schizophrenia following administration of aripiprazole im depot

Conditions: Schizophrenia

Summary: this study will evaluate the safety, tolerability, efficacy and pharmacokinetics of aripiprazole intramuscular (im) depot multiple doses every 4 weeks in adult patients with schizophrenia.


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia as defined by diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) criteria * good physical health as determined by normal medical history, clinical laboratory results, electrocardiograms (ecgs) and physical examinations * ability to provide informed consent and/or consent from a legally acceptable representation * body mass index (bmi) of 18 to 35 kg/m\^2 exclusion criteria: * sexually active males and females of child-bearing potential who are not practicing double barrier birth control or are not abstinent during the study plus 30 days for female or 90 days for males following the last dose of medication * history of drug or alcohol abuse within 6 months and/or positive urine drug screen * participants who consume alcohol beverages routinely * participants who consume alcohol beverages during the screening period * use of any antipsychotic medication, other prohibited psychotropic medication, and any cytochrome p450 2d6 (cyp2d6) and cytochrome p450 3a4 (cyp3a4) inhibitors or cyp3a4 inducers within 14 days * use of any prescription medication unless approved by medical monitor or study director * history of current hepatitis or carrier of hbsag (hepatitis b surface antigen) and/or hepatitis c virus antibodies (anti-hcv) * females who are pregnant or lactating * participants who have participated in any clinical trial involving a psychotropic medication within one month prior to enrollment; participants who have participated in a previous im depot study within the last 1 year; patients who have previously enrolled and received study medication in an aripiprazole im depot clinical trial * donation of blood or plasma to a blood bank or in a clinical study (except a screening visit)within 30 days prior to enrollment * any major surgery within 30 days prior to enrollment * blood transfusion within 30 days prior to enrollment * evidence of organ dysfunction or any clinically significant deviation from normal in the physical, electrocardiographic, or clinical laboratory examinations * patient represents a significant risk of committing suicide based on history * patients currently in an acute relapse * patients with axis i (dsm-iv) diagnosis of schizoaffective or bipolar disorder * patients who are considered treatment-resistant to antipsychotic medication * patients with a history of neuroleptic malignant syndrome * any other sound medical reason as determined by the clinical investigator